Cancer & COVID 19
Conditions
Brief summary
To determine the prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients (Part A). To evaluate the Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin (Part B).
Interventions
DRUGHydroxychloroquine
Hydroxychloroquine 200 mg 3 times a day for 10 days
DRUGAzithromycin
Azithromycin 500 mg on day 1 followed by 250 mg/day for 4 days
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All types of locally advanced and metastatic malignancy * Male/female participants * Age\>18 y.o. * Signed informed consent for participation in the study * No restriction on Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) Performance Status * Subject should not have received a prior systemic anti-viral treatment for Covid19 disease.
Exclusion criteria
* Patients with known hypersensitivity to hydroxychloroquine or chloroquine, azithromycin, erythromycin, or any other macrolide, ketolide or any of the excipients of the hydroxychloroquine and/or azithromycin-based specialty used. * Severe hepatic impairment and patients with severe cholestasis. * Patients with renal insufficiency with creatinine clearance \< 40 mL/min. * Combinations of drugs contraindicated in accordance with the approvals of the specialties used. * Patients currently treated with Tamoxifen * Patients already treated by hydroxychloroquine or azithromycin for Covid19 disease or currently treated with other antiviral drugs against coronavirus. * Patients with known contra-indication to treatment with the study drug, including retinopathy, G6PD deficiency, QT prolongation and severe hepato-cellular insufficiency. * Patients post allogeneic hematopoietic stem cell transplantation are eligible to the Part B treatments but the potential toxic effects of hydroxychloroquin and azithromycin on hematopoietic stem cells should be taken into consideration by prescribers. * Pregnant or breastfeeding women. Women of childbearing potential (WOCBP, as defined in appendix 2) should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients | Up to 3 months |
| Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin | Up to 12 months |
Countries
France
Contacts
Primary ContactLisa DEROSA, MD
Backup ContactStefan MICHIELS, MD
Outcome results
None listed